The Regulatory Liaison role is a broad role encompassing all aspects of regulatory strategy to support countries in region, including clinical, CMC and risk management requirements, and oversight of strategic regional labelling issues.
In this role, the Regulatory Liaison has responsibilities including:
- Serves as single POC for specific products for country and HQ.
- Provides regionally focused strategic input to product development across region and across portfolio.
- Contributes to region specific aspects of a development strategy.
- Leads identification of regional specific elements of submissions.
- Owns and leads the overall regional product regulatory strategy, including the corporation and maintenance of regulatory requirements for health authority registration approval.
- Monitors and communicates key strategic issues related to program progress and issues to/from countries and HQ.
- Manage the execution of Health Authority (HA) Response to Questions (RTQ) for both product marketing and assigned applications, and helps ensure HA deficiency letters are appropriately addressed in a timely manner
- Ensures alignment of strategy and priorities for portfolio of products with stakeholders, i.e. GHH, MMD.
- Contributes to development and execution of regional regulatory policy issues.
Below are the qualifications and skills required for this role:
- Bachelor graduate degree in Pharmacy, Biological Sciences, Chemistry, or related discipline required with at least 10 years experience in Regulatory Affairs. Individual with other relevant qualifications and substantial industry experience, supported by strong working knowledge of Regulatory Affairs or Clinical Research would be considered.
- Outstanding, interpersonal, written and verbal communication skills with strong collaborative skills and the ability to work both proactively and responsively in a fast-paced dynamic environment.
- Solid knowledge/experience with regulatory requirements & processes and registration guidelines for NCEs and product life cycle maintenance, preferably within Asia Pacific region.
- Collaborative team player with strong analytical judgment and problem-solving skills, capable of independently managing complex challenges and resolve issues efficiently.
- Demonstrated ability to assess, prioritize and manage multiple projects, tasks and responsibilities simultaneously.
- Proven ability to work independently and effectively within cross-functional and international teams.
- Strong ability to adhere to strict project timelines and deliverables.
- Highly detail- and goal-oriented, quality-driven and customer-focused.
- Fluent written and spoken English is required.
